Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Applicants’ amendments and arguments filed 06/22/2026 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim 1 is amended.
Claims 9-10, 12-13, 16-18, 21-22, and 29-32 remain withdrawn.
Claims 5-7, 11, 14-15, 19-20, and 23-28 are canceled.
Claims 1-4 and 8 are examined on the merits.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/16/2026 has been entered.
Terminal Disclaimer
The terminal disclaimer filed on 06/22/2026 disclaiming the terminal portion of copending application 18/516,295 on this application has been reviewed and is accepted. The terminal disclaimer has been recorded. It is noted that no additional Terminal Disclaimers or claim to any additional applications have been filed.
New Rejections Necessitated by Claim Amendments
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Momoi (US20090304601A1, published 12/10/2009, hereafter Momoi) in view of Bauer et al. (US20200038389A1, published 02/06/2020, hereafter Bauer).
Momoi claims a method of marking a composition for use in oral administration (title and claim 1; according to the claim limitations of the instant claim 1). Momoi claims dispersing a change in color inducing oxide in the composition (claim 1; according to the claim limitations of the instant claim 1). Momoi teaches the laser beam is at a wavelength of from 200nm to 1100nm (abstract and claim 12; according to the claim limitations of the instant claim 1). Momoi teaches the change in color inducting oxide is at least one that is selected from the group consisting of titanium dioxide, yellow ferric oxide, and red ferric oxide (abstract and claim 5; according to the claim limitations of the instant claims 1, 2, and 4). Momoi further teaches black-iron-oxide coating (table 2, comparative example 7; according to the claim limitation of the instant claim 4). Momoi teaches the capsules are made by filling a capsule coating layer which contains at least one type of metal oxide selected from the group consisting of titanium dioxide, yellow ferric oxide, and red ferric oxide ([0042]; according to the claim limitations of the instant claims 1, 2, and 4). Momoi teaches a soft capsule having a gelatin coating layer that contains glycerin ([0051]; according to the claim limitations of the instant claims 1 and 3). The same paragraph of Momoi teaches the capsule has a white color that after irradiation demonstrated a letter marking in a highly visible gray ([0051]; according to the claim limitations of the instant claim 1). Momoi teaches the composition have other additives to include plasticizers such as glycerin ([0044]; according to the claim limitations of the instant claim 3). Momoi claims the amount of titanium dioxide is from 0.01 to 20 parts by weight based on 100 parts of the coating layer (claim 10; according to the claim limitations of the instant claim 5). Momoi teaches the laser used is a Deep UV laser ([0053], table 3; according to the claim limitations of the instant claim 8). Lastly, Momoi teaches the active ingredients includes therapeutic drugs ([0043]; according to the claim limitations of the instant claim 1).
Although Momoi teaches the addition of titanium dioxide, it fails to teach the concentration as claimed by instant claim 1.
Bauer teaches a soft gelatin capsule embodiment for oral administration (title, [0018], [0140]; according to the claim limitations of the instant claim 1). Bauer teaches the invention in considered with administering therapeutic agents [0076]; according to the claim limitations of the instant claim 1). Bauer teaches an embodiment in which the capsules are liquid-filled ([0054]) and teaches in some embodiments the capsuled are filled with powder, beads, or granules containing the active ingredients in admixture with non-toxic pharmaceutically acceptable excipient which are suitable for manufacture of hard or soft capsules ([0142]; according to the claim limitations of the instant claim 1). Bauer teaches the soft capsule comprises a capsule shell comprising one or more pharmaceutically acceptable excipients selected from the group consisting of a gelatin shell, a plasticizer, an opacifier, and a colorant ([0212]; according to the claim limitations of the instant claims 1 and 3). Bauer teaches that plasticizers, opacifiers, and colorants are well-known in the art ([0212]; according to the claim limitations of the instant claims 1 and 3). Bauer further teaches the capsule shell comprises one or more pharmaceutically acceptable excipients selected from the group consisting of gelatin, glycerin, titanium dioxide, and iron oxide ([0212]; according to the claim limitations of the instant claim 1). Bauer teaches in some embodiments, the iron oxide comprises iron oxide (yellow) ([0212]; according to the claim limitations of the instant claim 4). Bauer teaches in some embodiments the soft capsule comprising about 0.01 to about 2% of titanium dioxide and about 0.1 to about 1% iron oxide ([0225]; according to the claim limitations of the instant claim 1). Lastly, Bauer defines “about” to be +/- 10% ([0059]; according to the claim limitations of the instant claim 1).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim an oral soft gel composition comprising a fill material and a shell comprising titanium dioxide and iron oxide as outlined by Momoi with the ready for improvement with the known technique of adjusting the concentration of the titanium dioxide as outlined by Bauer. Adjusting the forementioned components of a oral soft gel composition as claimed by instant claim 1 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13-14 of copending Application No. 17/629,126 (reference application) in view of Momoi (US20090304601A1, published 12/10/2009, hereafter Momoi). Although the claims at issue are not identical, they are not patentably distinct from each other.
17/629,126 claims a softshell capsule formulation comprising (a) a softshell composition comprising a natural gelling agent and a plasticizer; and (b) a fill composition (claim 1; according to the claim limitations of the instant claims 1 and 3). 17/629,126 claims the shell composition further comprises a colorant, wherein the colorant comprises at least one of iron oxide, iron hydroxide, titanium dioxide, or combinations thereof (claim 13; according to the claim limitations of the instant claims 1 and 2). 17/629,126 claims the softshell formulation further comprises an opacifier, titanium oxide (claim 14; according to the claim limitations of the instant claim 2).
17/629,126 fails to teach the capsule has a laser marking at a wavelength of about 100nm to about 400 nm and the marking has a different color than the capsule as in instant claim 1.
As outlined above, Momoi teaches a soft gelatin capsule composition with a UV laser, with a wavelength of 200nm to 1100nm, marking on a coating composition in which the marking is a different color than the coating and the coating has a fill material.
Further, both 17/629,126 and Momoi fail to teach the concentration of titanium dioxide as required by instant claim 1.
As outlined above, Bauer teaches a soft gelatin capsule comprising iron oxide and titanium dioxide, specifically titanium dioxide at a concentration of about 0.01 to about 2% ([0225]).
One skilled in the art before the effective filing date of the claimed invention would claim a softshell capsule with a gelling agent and plasticizer, an iron oxide colorant, and a fill composition as outlined by 17/629,126 with the ready for improvement with the known technique of marking the capsule with a UV laser at a wavelength of 200nm to 1100nm in which the marking is a different color then the capsule as outlined by Momoi. Adding the forementioned components to a softshell capsule as claimed by instant claim 1 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. Further, It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim an oral soft gel composition comprising titanium dioxide and iron oxide as outlined by 17/629,126 in view of Momoi with the ready for improvement with the known technique of adjusting the concentration of the titanium dioxide as outlined by Bauer. Adjusting the forementioned components of an oral soft gel composition as claimed by instant claim 1 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicant’s arguments filed on 06/22/2026 have been considered by the examiner.
In regards to the 35 USC § 103 rejection over Momoi, Applicant argues that Momoi fails to teach a concentration of titanium dioxide greater than 0% and less than 0.01% as required by instant claim 1.
It is first noted, that the previous rejection of record has been amended to include Bauer which teaches an oral soft gel composition with a shell ([0212]) and concentration of the titanium dioxide to include a range of about 0.01 to about 2% of titanium dioxide ([0225]) and defines “about” to be +/-10% ([0059]). Therefore, Bauer teaches a range of 0.009-1.8% of titanium dioxide which overlaps Applicant’s instantly claimed range. Applicant has failed to provide any additionally reasoning as to why the rejection over Momoi should be withdrawn.
In summary, Applicant’s arguments are not found persuasive. The rejection of record is maintained and updated to account for claim amendments.
In regards to Applicant’s argument against the Double Patenting rejections over 18/516,295, Applicant’s filed and approved terminal disclaimer overcomes the rejection of record. Thus, the double patenting rejection over application 15/516,295 has been withdrawn.
In regards to Applicant’s argument against the Double Patenting rejections over 17/629,126 in view of Momoi, Applicant argues that 17/629,126 does not teach the amount of titanium dioxide as claimed by instant claim 1.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, the rejection has been amended to incorporate Bauer which teaches the motivation to adjust the concentration of the titanium dioxide to include a range of about 0.01 to about 2% of titanium dioxide ([0225]).
Therefore, Applicant’s arguments are not found persuasive. The rejection of record is maintained and updated to account for amendments.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA NICOLE ISNOR whose telephone number is (703)756-5561. The examiner can normally be reached Monday-Friday 5:30am-3pm PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./ Examiner, Art Unit 1611
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